Quality of Life, Functional Evaluation, and Work Productivity in Patients With Narcolepsy: Results From a Phase 3 Study of Solriamfetol (JZP-110)

INTRODUCTION: Solriamfetol, a selective dopamine/norepinephrine reuptake inhibitor, significantly decreased excessive sleepiness in a randomized, double-blind, placebo-controlled study of adults with narcolepsy. Health-related quality of life (HRQoL) results (secondary endpoints) are reported here.

METHODS: Participants with narcolepsy (n=239) were randomized to solriamfetol (75, 150, or 300 mg) or placebo for 12 weeks. Assessments included Functional Outcomes of Sleep Questionnaire 10-item (FOSQ-10), Work Productivity and Activity Impairment questionnaire for Specific Health Problems (WPAI:SHP), and 36-Item Short Form Health Survey version 2 (SF-36v2). Least squares mean (standard error) changes from baseline to week 12 were calculated for each measure. Reported P values are nominal. Safety and tolerability were also assessed.

RESULTS: Solriamfetol 300 mg improved the FOSQ-10 (300 mg, 3.01 [0.42]; placebo, 1.56 [0.40]; P<0.05). Solriamfetol 150 mg reduced percent overall work impairment on the WPAI:SHP (150 mg, –19.77 [5.04]; placebo, –4.28 [5.00]; P<0.05) and reduced percent activity impairment at 300 and 150 mg (300 mg, –21.27 [3.55]; 150 mg, –17.84 [3.35]; placebo, –7.79 [3.42]; P<0.05). Improvements in SF-36v2 domains were seen for role physical (300 mg; P<0.05) and vitality (all doses; P<0.05). The most common treatment-emergent adverse events were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety.'

CONCLUSIONS: Solriamfetol improved functioning and HRQoL at 300 mg, specifically on the SF-36v2 vitality and role physical domains. Improvement in impairment at work (150 mg) and activity impairment outside of work (300 and 150 mg) was also demonstrated. Safety and tolerability were consistent with previous solriamfetol studies.